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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Paclitaxel
Trade Name:  Taxol
Date Designated:  03/25/1997
Orphan Designation:  Treatment of AIDS-related Kaposi's sarcoma.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  08/04/1997 
Approved Labeled Indication:  For the second line treatment of AIDS-related Kaposi's sarcoma.
Exclusivity End Date:    08/04/2004 
Exclusivity Protected Indication* :  
Bristol-Myers Squibb Pharmaceutical Research Institute
5 Research Parkway
P.O. Box 5100
Wallingford, Connecticut 06492
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.